Onyx Pharmaceuticals(ONXX) shares will likely take a hit Monday morning after the U.S. Food and Drug Administration rejected the company's request for an expedited, six-month review of the multiple myeloma drug carfilozimib.
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Instead, FDA said granted a standard, 10-month review time to carfilzomib, raising questions about whether the "benefit and risk" of the drug are balanced given that Onyx is seeking approval based on a single-arm study. FDA's approval decision date for carfilzomib is July 27, 2012, although the agency's comments suggest Onyx may need to submit additional clinical data on carfilzomib to get the drug approved. Onyx is running a large phase III study of carfilzomib with data expected in the first half of 2013, according to a company spokesperson. Onyx's setback opens the door for Celgene(CELG), which said Sunday night it intends to seek U.S. and European approval for its multiple myeloma drug pomalidomide based on data from a phase II study data.Ariad Pharmaceuticals(ARIA) highlighted improved interim results from a pivotal study of its experimental leukemia drug ponatinib on Sunday night.Following treatment with ponatinib, 47% of chronic myeloid leukemia (CML) patients with chronic phase disease had a major cytogenic, or cellular, response, meaning a reduction in the number mutated cells to less than 35%. In the subgroup of patients with the T315I mutation, the major cytogenic response rate was 65%. These are improved response rates compared to ponatinib data released from the same study in early November. The pivotal study of ponatinib, dubbed PACE, enrolled 450 CML and ALL patients, all of whom are either resistant to Novartis'(NVS) Tasigna or Bristol-Myers Squibb's(BMY) Sprycel, or who have a specific genetic mutation known as T315I that makes the leukemia resistant to current therapies.The data presented Sunday night come from an analysis of 392 patients with a median follow-up time of almost six months. Ariad expects the study to complete in the first half of next year.
Six percent of patients in the ponatinib study developed pancreatitis, inflammation of the pancreas, although no patients withdrew from the study due to the side effect. Four patients, all with advanced CML and other medical complications, died during the study and may have been related to ponatinib, researchers said.
Pharmacyclics(PCYC) showcased strong interim results from its leukemia drug PCI-32765 just a few days after licensing the drug to Johnson & Johnson(JNJ).
After 10 months of follow-up, 70% of chronic lymphocytic leukemia patients responded to a low-dose of PCI-32765. That's an increase from a 48% response rate reported last spring. Patients treated with a higher dose of PCI-32765 reported a 44% response rate after a shorter 6.5 months of follow up. All patients enrolled in the PCI-32765 study have CLL that is no longer responding to currently approved treatments."This is a potentially transforming drug for CLL," said Dr. John Byrd, professor of hematology and oncology at Ohio State University and an investigator in the PCI-32765 study. On Thursday, Pharmacyclics licensed PCI-32765 to Johnson & Johnson for $150 million upfront and as much as $825 million in future development milestones. PCI-32765 is a pill designed to block the production of an enzyme known as Bruton's tyrosine kinase that is responsible for the unchecked or cancerous growth of B-cells.YM Biosciences(YMI) will be presented highly anticipated data on its myelofibrosis drug CYT387 during a Monday night poster session starting at 9 pm ET. "Several key opinion leaders we spoke with said they believe '387's anemia benefits are real, even though they do not expect it to be quite as robust as previous results and do not have a scientific explanation for these effects," writes Wells Fargo biotech analyst Brian Abrahams. Sally Church, a cancer drug consultant who co-writes the popular Biotech Strategy Blog, tweeted last might, "Going to call it and say we won't see Hb [hemoglobin] increase with $YMI in tomorrow's #ash11 poster. Storm in a teacup."Researchers presented updated results from a pivotal study of Incyte's(INCY) recently approved myelofibrosis drug Jakafi showing a statistically significant, 50% reduction in the risk of death. However, given that the survival benefit was derived from a retrospective look at the data, it was unclear whether Incyte would be able to convince regulators to include the new claim in Jakafi's label. --Written by Adam Feuerstein in Boston.>To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein.>To submit a news tip, send an email to: tips@thestreet.com.Follow TheStreet on Twitter and become a fan on Facebook.
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